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Indian regulators have approved a generic version of Gilead’s hepatitis C drug Harvoni (ledipasvir-sofosbuvir) in a country with the highest infection rate on the planet. Read More
The FDA has granted orphan drug and rare pediatric disease designations to ARMGO Pharma’s ARM210 for the treatment of Duchenne Muscular Dystrophy. Read More
Physician groups frustrated with federal plans to pair different biosimilar drugs together for billing and reimbursement purposes are turning to Congress for help. Read More
Illegal conduct in the compounding and dietary supplement industries are two of the Department of Justice’s top three areas of increased focus, a deputy assistant attorney general said Wednesday. Read More
Teva, Eagle Pharmaceuticals Win FDA Approval for Bendeka
Pfizer Scores Approval, Priority Review for Two Drugs
Merck’s Keytruda Fields More Positive Trends in Blood Cancer Data
European Patent Office Backs Teva in Scrum Over Copaxone Patent
Boston Biotech Startup Partners With Roche to Develop Cell Therapy Treatment for Cancer Read More
With the price of opioid rescue drug naloxone nearly quadrupling in Baltimore last year, Baltimore City Health Commissioner Leana Wen called for a federal investigation into the drug, which holds a spot on the World Health Organization’s List of Essential Medicines. Read More
The FDA has blessed a new treatment for the bleeding disorder von Willebrand disease. The FDA disclosed Tuesday that it has approved California drugmaker Baxalta’s Vonvendi (recombinant von Willebrand factor) for on-demand treatment of adult patients with the inherited disorder. Read More
The FDA approved Alexion Pharmaceuticals’enzyme replacement drug Kanuma for an ultra rare disorder known as lysosomal acid lipase deficiency in pediatric and adult patients. Read More
The Secretary’s Advisory Committee on Human Research Protections is asking for more data on how proposed changes to the Common Rule requiring the use of a single IRB across a multisite trial could affect workflow. Read More
A law firm that represents drugmakers is urging the FDA to rethink its stance on granting meetings with senior FDA officials, saying the agency’s policy can imperil drug research. Read More